Identity
- Trade Name
- FIXOTAPE EUDAMED
- Device Name
- PLASTER EUDAMED
- Model / Reference
- FXT5502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683400978869 EUDAMED
- Basic UDI-DI
- 86834009FT7867KZ EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fixotape by Entpromed Sağlik Ürünleri̇ San. Ve Ti̇c. A.ş. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 86834009FT7867KZ | Class I | Active |
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Manufacturer
- Manufacturer
- Entpromed Sağlik Ürünleri̇ San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000022407
Sources (1)
- EUDAMED c388708e-a51b-417e-b522-2abc30c58376 61 fields · synced Oct 6, 2026